What is this study investigating about beta-blockers and aortic valve stenosis?

This study is evaluating how continuing or stopping beta-blockers affects patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. Researchers want to understand if beta-blockers influence the need for a permanent pacemaker and other heart-related outcomes after TAVI. The trial is led by the National and Kapodistrian University of Athens.

Who may be eligible for this aortic valve stenosis clinical trial?

Adults aged 18 or older with severe symptomatic aortic stenosis who are receiving beta-blockers and considered high risk for surgical valve replacement may be eligible. Patients must be suitable for TAVI and able to consent to follow-up. Patients with pacemakers, certain infections, or other medical conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this aortic valve stenosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID05721170

Randomized Study of Beta-blocker Use in Adults Undergoing TAVI for Severe Aortic Valve Stenosis Evaluating Effects on Pacemaker Need and Heart Outcomes

Led by National and Kapodistrian University of Athens · Updated on 2024-12-09

347

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the effects of beta-blocker use in adults undergoing transcatheter aortic valve implantation TAVI for severe aortic valve stenosis. This trial is a prospective, multicenter, randomized clinical study aiming to evaluate whether continuing or withdrawing beta-blockers around the time of TAVI affects the need for permanent pacemaker implantation and other cardiac outcomes. The study addresses a gap in knowledge about beta-blocker safety and impact during and after TAVI, a procedure increasingly used for high-risk patients with severe valve disease. Participants are randomly assigned to either continue taking beta-blockers or to stop them at least 72 hours before TAVI and for at least 7 days after the procedure. Treatment groups receive standard care, including antithrombotic and antibiotic medications, and undergo TAVI with decisions on valve type, anesthesia, and other procedural details made by experienced operators. After TAVI, beta-blockers may be restarted in the withdrawal group after 7 days, while the continuation group maintains beta-blocker use for the same period. The study includes a screening phase, randomization, treatment, and follow-up visits. During the study, participants will have medical history reviews, physical exams, ECGs, blood tests, and echocardiograms before and after TAVI. Follow-up visits occur at hospital discharge, 7 days, 30 days, and 12 months post-TAVI to monitor for pacemaker implantation, arrhythmias, mortality, shock, and conduction abnormalities. The primary outcome is the rate of permanent pacemaker implantation within 7 days of TAVI. Secondary outcomes include mortality and various heart rhythm and conduction issues over 12 months. Safety is closely monitored with protocol adherence and adverse event tracking throughout the study period.

CONDITIONS

Brief Title

Impact of Beta Blockers on TAVI (BETA-TAVI)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years old or older
Severe symptomatic aortic stenosis defined by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area < 1 cm2 or indexed aortic valve area < 0.6 cm2/m2
High risk for mortality with surgical aortic valve replacement as assessed by a Heart Team
Anatomic suitability for TAVI based on local Heart Team decision
Receiving beta-blockers as part of prescribed treatment
Understands trial purpose, risks, and benefits and willing to participate in follow-up
Provided written consent to participate in the trial

You will not qualify if you...

Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, titanium, nickel, cobalt, chromium, or contrast media
Presence of permanent pacemaker or defibrillator
Ongoing infection including active endocarditis
Echocardiographic evidence of left ventricular or left atrial thrombus
Contraindication to antithrombotic treatment
Estimated life expectancy less than 12 months
Pregnancy or pre-perimenopause
Second or third degree atrioventricular block
Bradycardia (heart rate < 50 beats per minute) at screening ECG
Co-morbidity interfering with follow-up visits
Enrollment in another competing or interfering study

Research Team

Leonidas Koliastasis, MD, MSc, PhD

Odysseas Katsaros, MD

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Randomized Study of Beta-blocker Use in Adults Undergoing TAVI for Severe Aortic Valve Stenosis Evaluating Effects on Pacemaker Need and Heart Outcomes

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria